Insertion of Risk Management in Quality Management Systems with the Advent of ISO 9001:2015: Descriptive and Content Analyzes

Rampini, Gabriel Henrique Silva; Berssaneti, Fernando Tobal; Saut, Ana Maria

doi:10.1007/978-3-030-14973-4_20

Cited by 5 publications

(5 citation statements)

References 26 publications

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“…The proposal of a model for risk approach makes a relevant contribution, both to the professionals of organizations and the scientific community, considering that the most widespread methods and methodologies contribute in a fragmented way to meet the requirements of ISO 9001:2015 related to risk-based thinking (Rampini et al, 2019;Martins & Silva, 2019), and considering the need to assist companies in understanding and applying the concepts related to risk management (Crovini et al, 2021), which is considered by SME, especially in the context of the standard requirements, one of the most difficult to understand and implement (Fonseca et al, 2019;Fonseca & Domingues, 2018;Rybski et al, 2017;Chiarini, 2017).…”

Section: Discussionmentioning

confidence: 99%

“…With the systematic presented in Figures 7 and 8, it works better with a deepening of each step, emphasizing the requirements established by ISO 9001:2015, which can be prepared by each organization, following the model's steps and the concepts presented in this paper. For both strategic and operational levels, the model follows PDCA cycle, emphasizing the need for a consistent planning and also, of the analysis of the realized process, identifying improvement opportunities continuously (Rampini et al, 2019;Samani et al, 2017). This way risk management becomes part of organizational culture, as required by ISO 9001:2015.…”

Section: Final Version Of the Proposed Modelmentioning

confidence: 99%

“…The search for certification in ISO 9001, as a basis for the structuring of a Quality Management System (QMS), is a practice used by SMEs as well as companies of the most diverse segments and sizes, as a way to ensure adequacy and effectiveness in their activities, processes, services, and products (International Organization for Standardization, 2019;Fonseca, 2015;Anttila & Jussila, 2017). ISO 9001:2015 has incorporated significant and challenging changes in its latest update, such as the concept of risk-based thinking (International Organization for Standardization, 2015; Rampini et al, 2019). However, the standard does not indicate how the new requirements should be addressed by each organization, leaving them the decision of what is more appropriate to their context (International Organization for Standardization, 2015;Fraser & Simkins, 2016;Ezrahovich et al, 2017;Vasile, 2017;Anttila & Jussila, 2017;Perdigão et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

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From theory to practice: a risk management model for SMEs in the context of ISO 9001

Martins

Silva

Gaudêncio

2021

Prod.

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Paper aims: To fulfill risk-based thinking (RBT), most companies opt for widespread methods as FMEA, even with their limitations. This research aims to develop a model for small and medium-sized enterprises (SMEs) relying on literature, practical and normative aspects, to accomplish RBT required by ISO 9001:2015.Originality: This study represents an original contribution once its analysis and results guide a highlighted need in the literature. By discussing RBT from three different perspectives, this paper provides relevant insights for researchers and practitioners in quality and risk management. Research method:The action research was conducted within a Brazilian SME, where the risk management model was implemented and analyzed through five cycles. The techniques to collect data were participant observation, documentary analysis, and semi-structured interviews, analyzed through attribute agreement analysis. Main findings:Unlike the isolated use of widespread methods, this model contains all the aspects needed for RBT. Its applicability is directly related to the level of experience on risks and ISO 9001, emphasizing the organizational aspects needed. Implications for theory and practice:A comprehensive model allows SMEs to understand better the concepts associated with RBT while incorporating an adapted approach to their contexts. Researchers can use the model to analyze its applicability for SMEs from different contexts.

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Section: Discussionmentioning

confidence: 99%

Section: Final Version Of the Proposed Modelmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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From theory to practice: a risk management model for SMEs in the context of ISO 9001

Martins

Silva

Gaudêncio

2021

Prod.

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“…ISO recognized the need to foster risk-based thinking beyond selective preventive methods in their renewed 9001 standard (International Organization for Standardization, 2016). Since then, the topic received strongly increased attention also in the academic literature (Martins et al, 2019;Rampini et al, 2019).…”

Section: Quality Risk Management In the Pharmaceutical Industrymentioning

confidence: 99%

Analysis of the effects of Operational Excellence implementation on Inspection Outcomes in the Pharmaceutical Industry: An Empirical Study

Eich

Friedli

2021

BJO&PM

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Goal: The goal of this paper is to test the possible connection between pharmaceutical manufacturing plants' Operational Excellence implementation and regulatory inspection outcomes.Design/Methodology/Approach: This paper uses logistic regression models on a unique dataset compiled from proprietary operations datasets and published FDA inspection outcomes. Results:The findings show that sites with advanced Operational Excellence implementation are more likely to receive favorable inspection outcomes and more so when specifically focusing on Total Quality Management implementation as a subset. A similar trend exists for the Quality Control laboratories and their compliance deficiencies when analyzed separately. Limitations of the investigation:The limitations of this research mainly lie in the limited size and composition of the available dataset. European manufacturing sites and quality control labs are overrepresented and the sample size for quality control labs is rather small.Practical Implication: This paper can help industrial managers and regulatory officials to better direct their resources to manufacturing sites and QC laboratories that are at a higher risk of quality non-compliance.Originality/value: It is a long-standing maxim in literature and practice that manufacturing sites shall build improvement capabilities to reach Operational Excellence which includes superior product quality. Quality Management is particularly important in the pharmaceutical industry and often evolves on its own in the organizations. Pharmaceutical production plants are inspected regarding their quality processes and systems by regulatory authorities. However, there is lacking published evidence of the interplay of Operational Excellence practices and regulatory inspection outcomes.

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“…Keywords were looked for in the documents' titles, abstracts, and keywords lists. Since it is a recent technological innovation, few related studies were found before 2014, but there was a significant increase in publications from 2017, and as in [27], conference papers were included in the analysis to capture the novelty of the subject. As a result, it was possible to identify the most searched keywords.…”

Section: Related Workmentioning

confidence: 99%

Placement of Infrastructure for Urban Electromobility: A Sustainable Approach

Machado

Takiya²,

Yamamura

et al. 2020

Sustainability

Self Cite

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Over the last few years, electric vehicles (EVs) have turned into viable urban transportation alternatives. Charging infrastructure is an issue, since high investment is needed and there is a lot of demand uncertainty. Seeking to fill gaps in past studies, this investigation proposes a set of procedures to identify the most adequate places for implementing the EV charging infrastructure. In order to identify the most favorable districts for the installation and operation of electric charging infrastructure in São Paulo city, the following public available information was considered: the density of points of interest (POIs), distribution of the average monthly per capita income, and number of daily trips made by transportation mode. The current electric vehicle charging network and most important business corridors were additionally taken into account. The investigation shows that districts with the largest demand for charging stations are located in the central area, where the population also exhibits the highest purchasing power. The charging station location process can be applied to other cities, and it is possible to use additional variables to measure social inequality.

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Insertion of Risk Management in Quality Management Systems with the Advent of ISO 9001:2015: Descriptive and Content Analyzes

Cited by 5 publications

References 26 publications

From theory to practice: a risk management model for SMEs in the context of ISO 9001

From theory to practice: a risk management model for SMEs in the context of ISO 9001

Analysis of the effects of Operational Excellence implementation on Inspection Outcomes in the Pharmaceutical Industry: An Empirical Study

Placement of Infrastructure for Urban Electromobility: A Sustainable Approach

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